NML TSH IRMA— 510(k) K852438

Substantially Equivalent

Nuclear Medical Laboratories, Inc.

FDA 510(k) clearance K852438 for NML TSH IRMA, Substantially Equivalent on 1985-07-12. Applicant: Nuclear Medical Laboratories, Inc..

Clearance details

Applicant: Nuclear Medical Laboratories, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1985-06-10
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.